SPECIAL NOTICE
A -- REQUEST FOR INFORMATION (RFI)- Mold Production and Characterization
- Notice Date
- 3/27/2012
- Notice Type
- Special Notice
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Environmental Health Sciences, Office of Acquisitions, Office of Management, 530 Davis Drive, Durham, North Carolina, 27713, United States
- ZIP Code
- 27713
- Solicitation Number
- NIHES-428-2012
- Archive Date
- 5/15/2012
- Point of Contact
- Patrick P Barbour, Phone: 919-541-7596, JoAnn K Lewis, Phone: 919-541-7894
- E-Mail Address
-
barbourp@niehs.nih.gov, lewisj@niehs.nih.gov
(barbourp@niehs.nih.gov, lewisj@niehs.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Request For Information "Mold Production and Characterization" "This is a Request for Information (RFI). This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this RFI is to obtain knowledge and information for project planning purposes." Background - The National Institute of Environmental Health Sciences (NIEHS) is one of 27 institutes and centers of the National Institutes of Health (NIH), Department of Health and Human Services (DHHS). The mission of the NIEHS is to reduce the burden of human illness and disability by understanding how the environment influences the development and progression of human disease. To have the greatest impact on preventing disease and improving human health, the NIEHS focuses on basic science, disease-oriented research, global environmental health, and multidisciplinary training for researchers. The NIEHS achieves its mission through •Extramural research and training, funded by grants and contracts, to scientists, environmental health professionals, and other groups worldwide; •Intramural research conducted by scientists at the NIEHS facility and in partnership with scientists at universities and hospitals; •Outreach and communications programs that provide reliable health information to the public and scientific resources to researchers; and •Toxicological testing and test validation by the National Toxicology Program (NTP). The NTP is an interagency program whose mission is to evaluate agents of public health concern by developing and applying tools of modern toxicology and molecular biology. The program maintains an objective, science-based approach in dealing with critical issues in toxicology and is committed to using the best science available to prioritize, design, conduct, and interpret its studies. To that end, the NTP is continually evolving to remain at the cutting edge of scientific research and to develop and apply new technologies. Molds include a variety of species of microscopic fungi that grow in the form of multicellular filaments, called hyphae. A connected network of branching hyphae is considered a single organism and is referred to as a "colony". A mold colony is often found in association with bacteria, which themselves vary depending on the nature of the mold colony including the species of mold present and the substrate upon which the colony is growing. Molds reproduce through the production of spores which are typically unicellular but can be sexual or asexual. Many species of fungi produce both types of spores. Spores can remain airborne indefinitely and are able to survive extreme fluctuations in temperature and humidity; once conditions are favorable the spore can develop into a new organism via mitotic division, producing a multicellular gametophyte, which eventually goes on to produce gametes. Common indoor molds include species of Cladosporium, Penicillium, Alternaria, and Aspergillus and under some conditions Stachybotrys. Some molds are used in the production of foods, beverages, antibiotics and enzymes, whereas others have been associated with human disease, particularly allergic reactions in sensitive people. Exposure to elevated levels of indoor mold has been associated with a number of symptoms: allergies, asthma, hives, itching, cancer, central nervous system problems, recurring colds, chronic cough, dermatitis, diarrhea, eye/vision problems, flu-like symptoms, headaches, hemorrhagic and hypersensitivity pneumonitis, kidney failure, and mental dysfunction including learning difficulties, personality changes, and memory loss. The Institute of Medicine has reported on the associations between exposure to damp indoor environments containing mold and human disease outcomes in Damp Indoor Spaces and Health, (The National Academy of Sciences, 2004). In this report the authors conclude that there is sufficient evidence of an association between exposure to damp indoor environments and some respiratory health outcomes in sensitized persons; suggestive evidence of an association between damp indoor environments and respiratory illness in otherwise healthy children; and insufficient evidence for determination of whether damp environments are related to a variety of health outcomes, including any association with Stachybotrys chartarum. The authors of the report identify many data gaps with respect to the role of mold in the areas of neurotoxicology, rheumatic diseases, reproductive effects and cardiopulmonary disease. In addition, it is unclear whether respiratory effects seen in otherwise healthy children exposed to damp environments are related to mold, bacteria, dust mites, cockroaches, or a combination thereof. Molds were nominated by an individual for study by the National Toxicology Program. In 2004 the NTP Board of Scientific Councilors and the Executive Committee endorsed the study of molds and suggested that the program consider studying organisms commonly found in indoor air (i.e.; Aspergillus and Penicillium) as well as Stachybotrys. In 2007 an Expert Review Panel was convened by the NTP to discuss study design. This panel identified several key areas, including growing conditions, life stage, and physical and chemical properties of molds as having a direct bearing on study design and potential study outcomes. Key recommendations of the panel were the use of single organisms as well as molds co-cultured on different building materials; production of a sufficient quantity of each mold, or mold co-culture that were harvested at a particular growth stage and dried for use in the entire study; and characterization of molds with respect to mycotoxins, glucans, allergens, particle size, protease activity, colony forming units, and spores. Purpose and Objectives - The purpose of this requirement will be the production of 6 molds in bulk form (dry powder), which will subsequently be used in NTP Toxicity testing. Molds to be produced will consist of two varieties of Stachybotrys sp. A greenish-black fungus that is found worldwide: •Stachybotrys chartarum isolate 1, a macrocyclic trichothecene chemotype; and •Stachybotrys chartarum isolate 2, an antranone chemotype Aspergillus versicolor, which is common on gypsum board, floor, carpet, mattress, and upholstered furniture dust, and damp walls; and Alternaria alternata, which is commonly isolated from plants, soil, food, and indoor air environment and is important in allergy, infection, and asthma severity. The NTP also plans to produce bulk quantities of two mold mixtures for subsequent testing, including a representative mold sample from a house damaged in Hurricane Katrina and a mold mixture from a known sick building. Project Requirements - The Tasks that will be performed under this requirement involve the processes, procedures, and facilities needed to grow and maintain mold colonies, collect and dry the mold to produce a powder suitable for use in inhalation studies, microscopically and chemically characterize, and determine the viability of mold colonies and the powdered material produced from them, and safely handle (store, ship, and/or manipulate) mold colonies and the produced powder, including providing written protocols documenting all procedures used. Mold colonies and mold powders will minimally be chemically characterized for mycotoxins, glucans, allergens, particle size, protease activity, colony forming units, spores, and endotoxins. Microscopic characterization will involve the identification of the significant mold species and exogenous substances present in the mold colony or powder. This effort has been divided into 8 objectives covering the program management and technical aspects of this project: 1.Program Management •Project management includes contract start-up, customer service, and continuity of services activities. •An effective Quality Assurance program, including a Quality Management Plan and SOPs for all work performed by the contract. •Effective communication between the Contractor and the NTP. •Implementation of an effective Information Management System including bioinformatics. •An effective health and safety program to ensure that work performed under the contract is done safely •Provision of adequate oversight so that work is completed in a timely and cost effective manner. •Accurate and timely reporting of financial data, administrative data, and work performed on the contract. 2.Procure, collect and/or isolate fungus •Procure fungi from commercial and/or academic sources and/or collect representative samples from a specified mold colony. •Isolate a single fungus species/strain from a multi-species source colony 3.Establish production colony •Activities associated with growing a specific fungal strain (or strains) from a commercial colony or a colony provided by the NTP or its designee. oThe colony may consist of a single fungus, or may be a mixture of several fungi and bacteria. oThe colony may be grown on a real-world substrate (e.g., gypsum board) or other substrate. 4.Develop methods •Development of microscopic methods to identify fungi present in a mold sample, confirm the presence of spores or spore fragments from marker organisms, identify bacteria present in a mold sample, and or provide a qualitative assessment of the homogeneity of a specified mold composite or sample. •Develop genetic or cell-based methods to confirm the identity of fungi and/or bacteria present in a mold sample or material, determine the number of colony-forming units in a mold sample or material. Determine the mutagenicity, cellular toxicity, or other endpoints for a mold or specified material. •Development of analytical methods for the characterization of a mold colony or powder with respect to homogeneity, particle size, species present (including colony forming units), mycotoxin, glucan, and allergen content, protease activity, other chemicals present, and presence of exogenous materials. 5.Scale-up •Development of procedures that will be used to produce a sufficiently large amount of a specified mold for use in a subsequent toxicology study. •Activities that are associated with growing a sufficient quantity of a specified fungus or fungi derived from one or more production colonies to produce the required amount of dried material. •The contractor will be expected to target the amount of fungi produced to an NTP-specified target mass of dried, processed fungus powder needed for a particular study, which is anticipated to be in the range of <100 g to ~50 kg. 6.Produce dried material •Activities needed to produce a dried material composed of a dried fungus or fungi fragments, including spores. These activities are divided into pilot-scale and bulk-scale activities, which are distinguished by the amount of dried material produced. oThe NTP anticipates that amounts of dried, sized material will range from < 100 g to ~50 kg for pilot-scale and bulk-scale production, respectively. •In some cases the dried material will be further processed to meet mass median aerodynamic diameter (MMAD) requirements for NTP inhalation studies (typically < 2 µm). 7.Characterization •All of the tests required to characterize the mold or finished dried, sized powder with respect to content (i.e., mold spores present; presence of hyphae or other fungal material; species and strain of fungus (or fungi) present; presence, and type (including species and strain) of bacteria; presence, and concentration of marker chemical compounds; presence, and type of substrate particles or other exogenous materials, including metals; particle size, colony forming units and enzyme activity. 8.Materials handling •Activities related to collecting, storing, manipulating, and shipping mold, mold colonies, and dried mold powders obtained or produced by the contractor. Successful contractors shall have the ability to perform the program management objective and assignments in at least two of the 7 technical objective areas, however, a single contractor need not have the capability to perform all of the assignments in all of the technical objective areas. Technical ObjectiveAnticipated Number of Assignments per Year Procure, collect and/or isolate fungus2 Establish production colony2 Develop methods5 Scale-up2 Produce dried material2 (pilot-scale), 1 (bulk-scale) Characterization3 Materials handling20 Anticipated period of performance - The Base Contract is anticipated from July 1, 2013 to June 30, 2016 with 7 optional 1 year periods of performance. If all options are exercised the period of performance shall extend through June 30, 2022. Other important considerations - Most of the testing performed under this contract shall be conducted in accordance with applicable GLP guidelines and where appropriate, NTP specifications (NTP, 2011). The contractor must have a currently functioning laboratory with demonstrated capability in related work. Combinations of assignments from different objectives will be considered single tasks with the understanding that multiple functional areas from different objectives will be needed to produce a required outcome. For example, an assignment to establish a production colony of S. chartarum may include obtaining the S. chartarum sample, establishing the colony, performing a qualitative assessment of the composition of the colony, and looking for marker compounds or performing a PCR analysis to confirm the presence of the desired mold species and strain (or absence of an undesired species and/or strain). The actual number of tasks will vary based on programmatic needs and availability of funds. Information sought - Respondents, please provide opinion(s) about the difficulty and/or feasibility of proposing the potential requirement as a cost reimbursement type contract. Provide possible solutions and approaches that may currently exist in the marketplace for procuring the outlined services under cost type contracts. Submission requirements - Responses must be received by April 30, 2012 3:00pm EST. Submit responses to the Contract Specialist identified above. The information can be provided in writing or electronically in Adobe PDF or Microsoft Word format. If hard copies are provided please submit an original and four (4) copies. Telephonic and facsimile responses will not be accepted. Limit responses to seven (7) pages maximum. Include the Request for Information (RFI) number and title in your response. Respondents are also asked to provide the following: DUNS number, organization name, address, technical and administrative points of contact (including names, titles, addresses, telephone and fax numbers, and e-mail addresses), and size and type of business (e.g., 8(a), HUBZone, WOSB, SDVOSB, etc.) "Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed. Information provided will be used to assess tradeoffs and alternatives available for the potential requirement and may lead to the development of a solicitation. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. Any solicitation resulting from the analysis of information obtained will be announced to the public in Federal Business Opportunities in accordance with the FAR Part 5. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s)."
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIEHS/NIHES-428-2012/listing.html)
- Place of Performance
- Address: Not known at this time., United States
- Record
- SN02707219-W 20120329/120328000044-2b3357772ef8adbba26a9c28b84f6101 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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